About Covid-19
F.D.A. advisers recommend updated boosters that target forms of Omicron. “An expert committee recommended Tuesday that the Food and Drug Administration plan on an updated booster shot of the coronavirus vaccines that targets some form of the Omicron variant that has dominated for months.
The panel’s vote paves the way for F.D.A. regulators to push for a new formulation for shots that the Biden administration hopes to offer later this year, before an expected winter resurgence of the virus.
The committee debated but did not specify which formulation might work best. The F.D.A. appeared to be leaning strongly toward a combination of the existing vaccine and two subvariants of Omicron, known as BA.4 and BA.5.”
If you are interested in the process that went into the decision, see: https://www.youtube.com/watch?v=BFdzNUus_CE
Pfizer CEO to Israeli TV: Omicron shots ready for use as soon as FDA approves “Revamped vaccines that protect against COVID-19 variants are ready to be shipped as soon as they are approved by US health authorities, Pfizer CEO Albert Bourla said on Israeli television on Sunday, as he visited Israel to receive the prestigious Genesis Prize.
The company’s original vaccine, the first shot to be made available against COVID-19, has been updated to fight the now-dominant Omicron variant and is set to be discussed by the US Food and Drug Administration (FDA) on Tuesday.”
Vaccine mandate for federal workers won’t go into effect until at least fall “The Biden administration’s coronavirus vaccination mandate for federal workers will not take effect at least until the fall.
The U.S. Court of Appeals for the 5th Circuit said Monday that it would reconsider a ruling by a three-judge panel that would have allowed the mandate to go into effect. The court, meanwhile, scheduled oral arguments for the week of Sept. 12.”
US government to invest up to $75mn in new Croda factory “The US government is investing up to $75mn in London-listed Croda’s new factory to shore up domestic production of a crucial component of mRNA vaccines, after the company provided the lipid nanoparticles for the BioNTech/Pfizer Covid-19 shot.
Croda, a speciality chemical manufacturer, is also investing up to $58mn in the new site in Pennsylvania as it seeks to expand its US manufacturing capacity.
The US Biomedical Advanced Research and Development Authority, which is charged with preparing the country for health crises, and an arm of the US department of defence are teaming up to invest in the site, which will support initiatives to prepare for any future pandemic.”
About health insurance
Anthem is now Elevance Health “The company formerly known as Anthem commemorated its official rebranding to Elevance Health on June 28 by ringing the opening bell at the New York Stock Exchange and beginning to trade under the new ticker symbol ‘ELV.’
The former Anthem website now reflects the name change, which is a combination of the words elevate and advance to represent the company's commitment to ‘elevating the importance of whole health and advancing health beyond healthcare for consumers.’"
Supreme Court won't take up lawsuit over PBM liability under ERISA “The Supreme Court declined to take up a lawsuit debating whether a pharmacy benefit manager has a fiduciary duty to lower drug prices, handing the industry a major win.
The court announced Monday it will not take up the class-action lawsuit John Doe vs. Express Scripts. The decision comes amid increased scrutiny from the federal government and Congress on the PBM industry’s role in the drug supply chain.
The lawsuit focuses on whether a PBM has a fiduciary duty under the Employee Retirement Income Security Act (ERISA) to lower drug prices if it has the ability to do so.”
Biden admin puts insurers on notice for compliance with ACA contraceptive mandate “Department of Health and Human Services (HHS) Secretary Xavier Becerra, Department of Labor Secretary Marty Walsh and Department of the Treasury Secretary Janet Yellen issued a joint letter to plan sponsors "reminding" them of their obligations.
The ACA mandates coverage for preventive women's health services, including contraceptive counseling and free birth control, for individuals and dependents. However, the secretaries say "recent reports" suggest insurers may not be holding up their end of the bargain.”
Two Individuals Convicted in $1.4 Billion Health Care Fraud Scheme Involving Rural Hospitals in Florida, Georgia, and Missouri “According to court documents and evidence presented at trial, Jorge Perez, 62, and Ricardo Perez, 59, both of Miami, Florida, conspired with each other and others to unlawfully bill for approximately $1.4 billion of laboratory testing services which were medically unnecessary, and that fraudulently used rural hospitals as billing shells to submit claims for services that mostly were performed at outside laboratories. Jorge Perez and Ricardo Perez also committed health care fraud on five specific occasions, and conspired to launder the proceeds of this fraudulent scheme…
The evidence showed that the defendants targeted and obtained control of financially distressed rural hospitals through management agreements and purchases. The defendants sought to obtain control of these rural hospitals because of private insurance contracts that provided for higher reimbursement rates for laboratory testing — a common feature of rural hospital contracts designed to ensure that the hospitals can survive and provide rural communities with much needed care. The defendants promised to save these rural hospitals from closure by turning them into laboratory testing sites, but instead billed for fraudulent laboratory testing worth hundreds of millions of dollars in a sophisticated and years-long ‘pass-though’ billing scheme. The scheme made it appear that the rural hospitals themselves did the laboratory testing when, in most cases, it was done by testing laboratories controlled by certain defendants.”
Biden Administration Announces New Model to Improve Cancer Care for Medicare Patients “Building on the lessons learned from the Innovation Center’s Oncology Care Model (tested from July 1, 2016 – June 30, 2022), EOM [Enhancing Oncology Model] is a voluntary model that will run for five years, from July 2023 through June 2028. Model participants will include oncology practices that treat people with Medicare undergoing chemotherapy for breast cancer, chronic leukemia, lung cancer, lymphoma, multiple myeloma, prostate cancer, and small intestine/colorectal cancer…
In addition to requiring participants to screen for health-related social needs, EOM includes other design elements that help drive CMS’ commitment to advancing health equity, including:
Offering an additional payment to participating oncology practices that provide Enhanced Services to patients who qualify for both Medicare and Medicaid,
Requiring participating providers to report patient demographic data (e.g., race, ethnicity, language, gender identity), and
Requiring participating providers to develop plans showing how they will address health equity gaps in their patient population.
A fact sheet on EOM is available at: https://www.cms.gov/newsroom/fact-sheets/enhancing-oncology-model”
About hospitals and healthcare systems
AMERICA’S MOST SOCIALLY RESPONSIBLE HOSPITALS FYI: From the Lown Institute.
National Hospital Flash Report: June 2022 “Takeaways at a Glance:
1.Nearly halfway through 2022, margins are cumulatively negative.
2. While some metrics have normalized, hospitals continue to perform below pre-pandemic levels, and there is an uncertain outlook for the rest of the year.
3.Elevated labor costs remain a significant challenge. Hospitals are still seeing higher labor costs and fewer hours worked, a sign of inflation and an indicator that long-standing labor shortages are likely worsened by increased turnover.
4.Warmer temperatures and ED visits drove up volumes and revenues. Patients often schedule elective procedures during the summer months, which may have contributed to growing volumes. Emergency department visits also spiked this past month as people spent more time outdoors.
5.Pent-up demand for hospital services also contributed to an increase in patients. Sicker patients continued to schedule procedures they had previously postponed, suggesting a return to normalcy as COVID-19 hospitalizations remained relatively low.
About the public’s health
The Supreme Court's abortion ruling shifts legal battles to state courts “Judges temporarily blocked abortion bans Monday in Louisiana and Utah, while a federal court in South Carolina said a law restricting the procedure after six weeks of pregnancy would take effect there immediately as the battle over the fall of Roe v. Wade shifted from the nation's highest court to courthouses around the country.”
Federal Workers Get Sick Leave for Health Travel With Roe Voided “Federal Workers Get Sick Leave for Health Travel With Roe Voided. Federal employees can use sick leave to travel for medical care, the Office of Personnel Management said Monday, days after the Supreme Court overturned Roe v. Wade and allowed states to ban abortion.”
About healthcare IT
HIPAA won’t protect you if prosecutors want your reproductive health records With Roe v. Wade now overturned, patients are wondering whether federal laws will shield their reproductive health data from state law enforcement, or legal action more broadly. The answer, currently, is no.
If there’s a warrant, court order, or subpoena for the release of those medical records, then a clinic is required to hand them over. And patients and providers may be made legally vulnerable by the enormous trail of health-related data we all generate through their devices every day.
As far as health records go, the most salient law is HIPAA — the Health Insurance Portability and Accountability Act. It’s possible that federal officials could try to tweak it, so records of reproductive care or abortion receive extra protection, but legal experts say that’s unlikely to stand up in the courts in a time when many judges tend to be unfriendly to executive action.”
Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis “Several studies have highlighted the need for greater clinical validation and found that many solutions were not supported by robust clinical evidence and demonstrated mixed results on cost savings and cost-effectiveness. In addition, there is evidence that some claims made by digital health companies have been misleading…”
”A total of 224 digital health companies with an average age of 7.7 years were included in our cohort. Average clinical robustness was 2.5 (1.8 clinical trials and 0.8 regulatory filings) with a median score of 1. Ninety-eight (44%) companies had a clinical robustness score of 0, while 45 (20%) companies had a clinical robustness score of 5 or more. The average number of public claims was 1.3 (0.5 clinical, 0.4 economic, and 0.4 engagement); the median number of claims was 1. No correlation was observed between clinical robustness and number of clinical claims (r2=0.02), clinical robustness and total funding (r2=0.08), or clinical robustness and company age (r2=0.18).”
About health technology